GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED A 3.0MM COUPLER WAS MISALIGNED. DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE SPIKE OF THE COUPLER APPEARED MISALIGNED. THE SURGEON THEN HAD TO CUT THE ANASTOMOSIS AND PERFORM IT AGAIN WITH A NEW COUPLER. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

CORRECTION: B3: EVENT DATE WAS REPORTED AS JUNE 6, 2024 NOT MAY 6, 2024 H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PROVIDED PHOTOGRAPHIC SAMPLES, A SLIGHT RING MISALIGNMENT WAS NOTED. IT IS UNKNOWN IF THE RINGS WERE INSPECTED PRIOR TO EVERTING THE TISSUE ONTO THE PINS TO ENSURE THE RINGS WERE IN ALIGNMENT. THERE IS POTENTIAL THAT PREPARATION FOR OR USE OF THE 3.0MM COUPLER IN THE SURGICAL PROCESS MAY HAVE CONTRIBUTED TO THE ALLEGATION OF THE COUPLER PRODUCT NOT ALIGNING PROPERLY. IF UNDUE PRESSURE WERE TO BE PLACED ON THE COUPLER RINGS DURING EVERSION OF THE TISSUE ONTO THE PINS THERE IS POTENTIAL THAT THE COUPLER RINGS MAY MOVE WITHIN THE JAW ASSEMBLY WHICH COULD LEAD TO A MISALIGNMENT BETWEEN THE PINS ON THE TWO COUPLER RINGS WHEN THEY ARE APPROXIMATED. THE REPORTED CONDITION WAS VERIFIED. DUE TO THE NATURE OF THE PROVIDED SAMPLE, NO FURTHER TESTING COULD BE PERFORMED. THEREFORE, THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.